Breast lumpectomy for breast CA is an imprecise procedure that too often results in cancerous tissue being left behind. About a quarter of patients have to come back and go through the surgery yet again.
This is in large part due to the fact that guidewires are the standard way to point to the location of a tumor. While guidewires are better than nothing, they are crude and not very precise. Radioactive seeds are another option, but they have safety concerns and radio-based technologies are limited in their targeting and they can interfere with other equipment.
Engineers at Boston University have now developed an optoacoustic system that doesn’t rely on guidewires, radiation, or radio waves to localize a tumor with a great level of accuracy. Their AcouStar technology uses an optical fiber as the guidewire, but it’s used to send short pulses of laser light into the tumor. The light pulses heat and expand the tumor tissue, generating ultrasound waves that propagate from the tumor. Three ultrasound detecting patches attached to the skin of the breast allow the system to triangulate the location of where the ultrasound waves are coming from, and therefore the location of the tumor.
The system so far has been tried on a cadaver, with very promising results. Next steps will involve further testing and clinical trials, but the technology is already creating a lot of hope that lumpectomies can be made more precise and revision surgeries will become a rarity.
Using lab animals in medical science is not only an ethical issue, but the research findings often don’t match up to what happens in humans. Simulating various natural processes within microfluidic devices often a provides a more reliable, and easier to work with, laboratory technique over live animals.
Researchers at Purdue University have built a microfluidic device that will help them understand the relationship between blood clots and pancreatic tumors. Pancreatic cancer seems to lead to increased clot formation, which may be a major factor in this cancer’s ability to quickly growth and spread throughout the body. Moreover, clots make it harder for drugs to reach tumors.
The Purdue hope that the knowledge they gather with the help them and partner teams at Cincinnati Children’s Hospital, the Indiana University School of Medicine and the University of North Carolina School of Medicine at Chapel Hill, to develop new therapies to address pancreatic cancer.
Their new microfluidic device has tunnels that are home to tiny pieces of live pancreatic duct tissue, positioned below a microslide. The tissue can be closely monitored and the environment changed to assess how the tissue responds to different stimuli.
It will be used with both animal tissue and diseased human samples to eventually confirm that it’s performing as desired and to begin thinking of new therapeutic approaches.
Medical radioisotopes are widely used in cancer treatment, but their production has been hampered to the point that obtaining them has become a challenge. The lack of Technetium-99m is probably the most widely known, but there’s also a shortage of Iodine-131 (I-131), a radioisotope commonly used for diagnosing and treating thyroid conditions because the thyroid absorbs iodine naturally.
Things are now looking up as the University of Missouri Research Reactor (MURR), a 10 megawatt reactor, has just produced the first commercial batch of I-131. International Isotopes, Inc. is the buyer and distributor. This is the first supplier of I-131 to be based in the United States since the 1980s, and so should help to guarantee the availability of the radioisotope for many years. It was first approved by the FDA in 1951, but because of a half life lasting just over a week, the material requires constant and consistent production.
“Having MURR as a domestic producer for I-131 provides a much higher level of stability and reliability in the U.S. for this important isotope,” said Steve Laflin, president and CEO of International Isotopes, Inc. (INIS). “INIS has been supplying I-131 throughout the U.S. for nearly 15 years using only foreign sources of supply. We are pleased to have an opportunity to enter into a long-term supply agreement, and INIS plans to utilize MURR as one of our major suppliers for I-131 in the future.”
An amazing new PET/CT scanner has produced its first images of human subjects, giving scientists and clinicians new opportunities to treat cancer and other diseases. The EXPLORER is a high sensitivity total-body positron emission tomography scanner developed by a collaboration of many different scientists. It is capable of imaging the entire human body in less than a second and with excellent fidelity.
It was originally conceived by Simon Cherry and Ramsey Badawi, two scientists at UC Davis, but years of engineering and scientific work was required to turn it into reality. The first model was eventually built by United Imaging Healthcare out of Shanghai, China, and the company is working toward commercializing it and bringing it to clinics and research laboratories. The scanner’s first work has been conducted at the Department of Nuclear Medicine at the Zhongshan Hospital in Shanghai.
Because of the scanner’s high efficiency, it is able to produce images in as little as a second using a standard radiation dose, much faster than with conventional devices. Moreover, to help reduce radiation exposure, the dose can be reduced at the expense of just a few extra seconds of the scanner’s time. And if optimal image quality is key, a longer scan at a standard dose will provide impressive results.
The developers of the device believe that new whole-body studies, which can assess how different tissues and organs react to different stimuli, will be able to be performed. The spread of inflammation, the impact of different disorders, and the mobility of cancer tumors should also be subject to easier assessment using the new scanning technology.
The researchers will be presenting the first scans of people using the system at the upcoming RSNA conference in Chicago.0
Butterfly Network, a firm based in Guilford, Connecticut, won FDA clearance and is introducing its Butterfly iQ portable ultrasound system. It consists of a portable transducer that connects directly to an iPhone, and an iOS app to display the images and to control settings.
The device actually works as three different transducers thanks to an ultra wide band matrix array. This allows a clinician to perform a bunch of different scans and for the Butterfly iQ to be applicable in different clinical settings. The matrix array of microelectromechanical (MEMS) sensors is directly integrated onto an integrated circuit that contains all the necessary electronics. This tight integration supposedly results in a fast, high-resolution device that can perform tasks that only full size ultrasound machines were capable just a few short years ago. The firm compares its technology to how photo camera sensors have been integrated within smartphones, enabling anyone to have high quality photo imaging in their pocket.
Perhaps the biggest deal with the Butterfly iQ is that it costs under $2,000. Previous portable, hand-held ultrasounds have often been priced at more than $10,000.
Hologic is releasing in the U.S. its MyoSure MANUAL device for in-office removal of intrauterine fibroids and polyps. It’s used with the company’s MyoSure hysteroscope, which provides direct visualization. The device has a blade that can be rotated a full 360° and the treatment doesn’t require cauterization.
The MyoSure MANUAL doesn’t require a separate vacuum or fluid management system, as it has a built-in vacuum that empties into a connected saline bag. There’s a tissue trap that can hold approximately four grams of resected material that can be popped off and sent straight to the pathology lab.
“The MyoSure MANUAL device is an exciting addition to Hologic’s growing portfolio of gynecologic solutions, developed with the patient and physician in mind,” in a statement said Sean Daugherty, President of GYN Surgical Solutions at Hologic. “This addition to the MyoSure product suite signals our ongoing commitment to providing effective surgical solutions that can be performed in office to address our customers’ needs and improve the overall patient experience.”
Healcerion, based in South Korea, was the first company to receive FDA clearance for their wireless, app-based ultrasound system back in 2015. The groundbreaking work done by South Korean engineers and scientists laid the foundation for the development of an ultrasound transducer that works with most smartphones or tablets. Since introducing the SONON 300C convex transducer, the company has been making progress to further advance this branch of ultrasound devices. Their latest, the SONON 300L linear transducer, weighs only 13 ounces (370 grams) including the battery, and features color doppler mode for easier musculoskeletal (MSK), vascular, small parts (breast, thyroid), lung imaging, and much more.
The SONON series can be used to connect and transmit through Wi-Fi as well as 3G/LTE, so doctors always have an Internet connection, even in many remote regions of the world. Its size, weight, and capabilities, along with the three hour scan time make it perfect for emergency and everyday use. The FDA approval for SONON 300L shows that app-based ultrasound is continuing to move forward. While it cannot yet replace conventional full-size ultrasound systems, it’s important to remember that computers used to take up whole rooms too, but now smartphones are even more powerful than those behemoths once were.
Healcerion CEO, Dr. Benjamin Ryu said, “A pediatrician from Africa recently told us that when imaging a 2 month old baby, they found hydrocephalus, fluid buildup in the brain. The doctor took an image she captured with our system and sent it to a neurosurgeon through WhatsApp, who then determined that surgical intervention would be required to remove the fluid. This example shows the true potential of our system for telemedicine applications and beyond.”
Cambridge Medical Robotics (CMR), based in the UK, is working on revolutionizing the world of surgery by delivering what the firm believes is the next generation surgical robot. More versatile, affordable, and easier to use than other robots on the market, CMR’s Versius system is already generating significant interest. The company announced in September that it had closed the series-A funding round with $26 million of investment, following an initial round of more than $20 million at the end of last year.
The company’s mission is to make minimal access surgery available to all those who need it by breaking down the barriers that currently exist, including the size, cost, and complexity of current surgical robotic systems
Versius, CMR’s first robot, uses five self-contained robotic surgical arms that are part of a slim, modular system. Each arm contains all the intelligence and sensing capabilities needed to move itself in response to a surgeon’s commands and it also responds to the touch of the assisting surgical staff. The modular design allows for a surgeon to remove arms that are not needed for a procedure. To achieve the required level of precision, the arms self-monitor their position and the force they apply 5,000 times per second, which can be compared to a full-speed fighter jet measuring its location every 4 inches (10 cm).
We had the pleasure of speaking to CMR’s CEO Martin Frost about his vision behind the startup and the company’s growth plans in the coming years. Mr. Frost is an experienced commercial business leader, with over 20 years of experience in starting, growing, and leading technology and medical device companies.
Alice Ferng, Medgadget: Tell me about Cambridge Medical Robotics.Who’s the force behind your invention and what is your personal background?
Martin Frost, CEO of Cambridge Medical Robotics: Cambridge Medical Robotics is 150 people. We have accreted those people in three and a half years. The company was started in January 2014, and we anticipate being in a 15,000 sq ft building in North Cambridge within a year, which is a significant investment in doing manufacturing, integration, assembly in the Cambridge area.
I am 1 of 4 people who started the company. All of us have worked closely together in the Cambridge, UK area. We have worked a lot in medical devices, R&D, and consulting. My own background is that this is the sixth company that I have been involved in starting and building. I’ve been very fortunate that two of those companies have been listed on the London Stock Market. The reason we [Cambridge Medical Robotics] exist is that we all came together to solve a big problem: we believe that there are millions of people a year that don’t receive the right surgery, despite the fact that robots are not a new idea in the operating room.
If you look at the world today, there are 4,000 robots, doing 750,000 procedures, but the vast majority of these surgeries are in the area of urology. We believe that what the market needed was a far more adaptable robot that could be afforded at a better price.
Medgadget: What types of surgical applications are you targeting? How does your Versius robot differ from a system like the da Vinci from Intuitive Surgical that has been out in the field for a while?
Mr. Frost: The history of the da Vinci robot is that it was initially designed for mitral valve repair, but since then, the majority of the procedures it has been used for has been in the field of urology. We are a multispecialty robot working in all quadrants of the body, which more naturally lends itself to operations in general surgery, the lower and upper GI, colorectal, and hernia indications.
If you look at our technology and what we are providing – it’s a far more flexible, modular robotic platform where a piece of the robotic arms can be placed flexibly around the patient in the operating room. This makes it easier for the staff to work with and move around the robot and patient in the operating room as compared to other robots.
Medgadget: Can you give me an idea of the portability and sizing of your robot?
Mr. Frost: These robots are lightweight, and therefore also portable, and transportable. The existing robots are about 800kg [1,700 lbs] heavy. Our modular robotic arms – the first version of which will be on a cart – are less than 15kg [33 lbs] each.
We haven’t just designed these robotic arms to adapt to current systems, but instead have designed from the ground-up a new modular system that incorporates newer technologies and materials that did not exist 20 years ago. This has enabled us to build something that is significantly differentiated from what exists today.
Medgadget: You’ve mentioned the goal to reduce differences in cost to make your robot more affordable. What does this look like?
Mr. Frost: At present, the existing robots are sold as expensive capital, and the consumables can be around 2,000-3,000 British pounds [~$2667-$4000 USD] each for 10 uses. The whole lifetime cost for an existing robot can therefore be around 6 million pounds in the UK [$8 million USD], which is very expensive for hospitals that have very little money.
We intend to supply our system as a service, including the robot, all of instrumentation, and maintenance as part of a contract at a fixed annual cost. And we intend to reduce the whole lifetime cost for a hospital by as much as 30 to 40 percent.
Medgadget: What about your console and its user interface that make them more easily accessible compared to other robots?
Mr. Frost: The da Vinci System is similar to a periscope system, where the surgeon is hunched over the console. Frankly, there are a lot of surgeons who like that, and there are other surgeons who do not like that. But a majority of surgical staff do not like this. They prefer open communication with the surgeon during the course of the procedure. We have therefore designed our console to be open. The surgeon can either sit or stand up during the procedure. We have a more modern console interface that is almost like gaming, and have received positive feedback for this. It is also slimmer and more portable than the da Vinci console.
Medgadget: Do your controls include features such as haptic feedback?
Mr. Frost: While our controls can enable haptic feedback, it is likely that our first robots we will launch will not enable that feature. We do have it planned already though. We have done more than a dozen usability studies with a lot of feedback from surgeons. Some surgeons actually prefer the optical feedback that they get from the operating system.
One to two of our competitors already have systems with haptic feedback, and we are still working with surgeons to determine if they do or do not like this feature.
Medgadget: What are your growth plans for your company moving forward? Will you be building other robots and targeting other areas of medicine in the future?
Mr. Frost: We will launch our product initially in Europe, and we anticipate having a number of systems being used in the UK by the end of next year. We anticipate being in the United States in 2019. So the hope is to get from 20-30 systems to 100 or more over the course of three years. In the end, the market appetite for what we are doing for next generation robots is hundreds of systems per year. For example, Intuitive Surgical sells about 400 systems a year today. Most people see the existing market growing by at least five times over the course of the next 10 years, and we would agree with them.
We are a British company, not from the United States or California, and therefore this has both advantages and disadvantages. We are very familiar with the constraints hospitals have to operate in in Europe. This means that we spend a good deal of time figuring out how we best position ourselves for this market. Being small means that we do not already have an existing business. We can take a commercially flexible approach to this market.
We are very much looking forward into building a larger medical device company. We deliberately named our company “Cambridge Medical Robotics” because we plan to build other robots moving forward. However, our most important priority is to get good feedback from our first robot Versius, and then to go from there.
At last week’s RSNA conference in Chicago, we got a chance to learn about Seno Medical Instruments, a San Antonio, Texas company, and its imaging technology that combines conventional ultrasound with a new modality called optoacoustic imaging. We spoke with Dr. Tom Stavros, Medical Director at Seno.
The company’s Imagio system relies on a duplex probe that looks and acts like a regular ultrasound transducer, but that also emits laser light to simultaneously work as an optoacoustic imaging device. In optoacoustics, laser light is used to add energy to tissue, which is then released in the form of ultrasound waves. These waves can be detected, but unlike conventional ultrasound, they contain information about blood and its oxygenation. Ultrasound is pretty good at seeing the structures of tissues, and in this device, optoacoustics provides the functional view of blood oxygenation and improves the contrast, which can make it critically important for spotting tumors, as tumors eat up a lot more oxygen than nearby tissues.
The Imagio system is intended for breast cancer diagnostics rather than screening, and patients are expected to have been screened using ultrasound before being imaged by Seno’s system. Roughly 80% of breast biopsies turn out negative these days, a disturbingly high number, so anything to improve this would be highly beneficial for reducing costs, improving the emotional well being of patients, and getting the right people quicker from screening to treatment. To that effect, clinical trial data has just been released at RSNA that shows that the Imagio can reduce false positives breast exams and benign biopsies.
The system images at 30 frames per second using ultrasound and at 10 frames per second via optoacoustics. The optoacoustic component relies on shining two wavelengths (long and short) of light sequentially. The long wavelength is absorbed by oxygenated blood, while the shorter one is more readily absorbed by deoxygenated blood, providing a view of both and a contrast between regions of varying oxygenation.
We checked out a bunch of images of scans performed by the Imagio, which have red color showing deoxygenated blood and green color highlighting oxygenated regions. The images are created by sweeping the Imagio probe across the lesion, including a few centimeters around the lesion. By understanding the morphology of the vasculature that feeds a tumor and how it consumes oxygen, one can identify tumors in some cases while ruling them out in others with pretty good accuracy.
Prescient Surgical, based in San Carlos, California, just won FDA marketing clearance for its CleanCision Wound Retraction and Protection System. The device, which combines a retractor with infection control mechanisms, aims to prevent surgical site infections, a common, dangerous, and costly problem.
The CleanCision System protects surgical wounds by covering them and the surrounding tissues with a waterproof material, while providing irrigation and suction along the edge of the wound.
The device is placed into the wound and pulled apart in an intuitive fashion, opening up like a flower. The clinical staff can choose the irrigation liquid to pump through the CleanCision System, which helps to wash away any bacteria that may be present on the wound.
So far, in studies of the device, the CleanCision system was able to achieve a 61% reduction in surgical site infections, an impressive achievement.
“We are initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high and the need is acute,” said Jonathan Coe, cofounder, president and CEO of Prescient Surgical. “Our team collaborated closely with leading hospitals in abdominal surgery to create a technology platform and product that could be used in the full range of open and minimally invasive approaches utilized in their procedures. The result is an intuitive system that readily integrates into surgical workflow,” he added.